SpecGx Oxycodone and Acetaminophen CII Tablets Recall (Class II)

Why it was recalled

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Product description

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.

Lot numbers, UPCs & expiration codes

Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0254-2026
Classification: Class II
Status: Ongoing
Recall initiated: Dec 16, 2025
FDA report date: Jan 14, 2026
Quantity: 287,988 Bottles.
Recall type: Voluntary: Firm initiated
Recalling firm: SpecGx, LLC

Original FDA data

Every field from FDA enforcement report D-0254-2026, exactly as published.

Show all FDA fields

City: Webster Groves
State: MO
Status: Ongoing
Country: United States
Event ID: 98136
Address: 385 Marshall Ave
Code information: Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
Postal code: 63119-1831
Report date: Jan 14, 2026
Product type: Drugs
Recall number: D-0254-2026
Classification: Class II
Recalling firm: SpecGx, LLC
Product quantity: 287,988 Bottles.
Reason for recall: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Distribution pattern: Nationwide
Recall initiation date: Dec 16, 2025
Initial firm notification: E-Mail
Center classification date: Jan 7, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0254-2026, published Jan 14, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

SpecGx Oxycodone and Acetaminophen CII Tablets Recall

Summary